Status:
COMPLETED
Study Evaluating Pantoprazole in Children With Gastroesophageal Reflux Disease (GERD)
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
Nycomed
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
1-5 years
Phase:
PHASE3
Brief Summary
To evaluate the clinical outcomes of treatment with oral pantoprazole in children 1 through 5 years of age with endoscopically proven symptomatic GERD.
Eligibility Criteria
Inclusion
- Ability to undergo endoscopy with required biopsy
- Ages 1 through 5 years
- Endoscopically confirmed GERD by positive endoscopic evidence of reflux related esophagitis or positive histologic evidence of esophagitis consistent with GERD Other inclusions apply.
Exclusion
- History or presence of upper gastrointestinal anatomic or motor disorders
- Known current or active cow's milk allergy
- Malignancy
- Other exclusions apply.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00300755
Start Date
May 1 2006
End Date
April 1 2008
Last Update
May 19 2010
Active Locations (43)
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1
Mobile, Alabama, United States, 36604
2
Phoenix, Arizona, United States, 85016
3
Oakland, California, United States, 94609
4
Orange, California, United States, 92868